Unichem Labs wins USFDA nod for pain management drug Tramadol Hydrochloride tablets
The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Unichem's Tramadol Hydrochloride tablets USP, in the strength 50 mg, Unichem Laboratories said in a regulatory filing on Tuesday.
New Delhi: Drug firm Unichem Laboratories has received approval from the US health regulator to market pain management drug Tramadol Hydrochloride tablets.
The company has received abbreviated new drug application (ANDA) approval from the US Food and Drug Administration (USFDA) for Unichem's Tramadol Hydrochloride tablets USP, in the strength 50 mg, Unichem Laboratories said in a regulatory filing on Tuesday.
Also Read: Unichem Labs gets tentative USFDA nod for a generic version of JnJ Zyrtec-D 12 Hour
The approved product is a generic version of Ultram tablets, 50 mg, of Janssen Pharmaceuticals, Inc.
Tramadol Hydrochloride tablets are indicated for use in adults for the management of pain severe enough to require an opioid analgesic, and for which alternative treatments are inadequate.
Unichem said the product will be commercialised from its Ghaziabad, Uttar Pradesh, plant.
Also Read: Unichem Labs Ghaziabad facility successfully completes USFDA inspection
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